Cell Therapy With Bone Marrow Mononuclear Cells in Critical Leg Ischemia (CLI)

February 13, 2009 updated by: University of Paris 5 - Rene Descartes

Optimisation d'un Produit de thérapie Cellulaire Autologue Par Cellules mononucléées médullaires Dans l'ischémie Critique Des Membres inférieurs liée à l'athérosclérose

This study will treat by cell therapy 20 patients with critical leg ischemia (CLI) not eligible for revascularization or angioplasty. It will use exactly the same protocol as published by Tateishi-Yuyama et al. (Lancet 2002), using bone-marrow mononuclear cells (BMMNC).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients will be included with CLI according to the TASC criteria. Under general anesthesia, 500 ml of bone marrow is harvested in both iliac crests. After isolation and concentration of the BMMNC in 30 ml, 40 injections of around 0.75 ml will be done in the gastrocnemius of the ischemic leg, within 3 hours after preparation of the cell therapy product.

Patients will then be followed-up every week during one month and then every month during one year.

This study was approved by the ethical committee of Paris-Broussais HEGP (France) and our french regulatory agency (AFSSAPS).

It began including patients in January 2005 and will last until December 2007.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Emmerich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18
  • Signature of informed consent
  • Critical leg ischemia with ankle pressure < 70 mmHg
  • Ischemic ulcer or gangrene
  • No possibility of surgical revascularization
  • No possibility of angioplasty

Exclusion Criteria:

  • Cancer
  • Suspicion of a cancer on X-Ray, mammography or elevated PSA
  • Age < 18
  • Life expectancy < 6 months
  • Active retinopathy
  • Angioplasty or surgical revascularization within 3 months
  • Stoke within 3 months
  • HIV + or HCV/HBC+

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ankle brachial index
Time Frame: 6 months
6 months
Healing
Time Frame: 1 year
1 year
Amputation rate
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
TcPO2
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Paris 5 - Rene Descartes

Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Joseph Emmerich, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ANTICIPATED)

September 1, 2008

Study Completion (ANTICIPATED)

December 1, 2009

Study Registration Dates

First Submitted

September 18, 2006

First Submitted That Met QC Criteria

September 18, 2006

First Posted (ESTIMATE)

September 19, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 16, 2009

Last Update Submitted That Met QC Criteria

February 13, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPTIPEC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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